Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
1 other identifier
observational
390,659
1 country
1
Brief Summary
This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with Rotarix within 60 days of vaccination in a real life setting (routine use) in the US. This study will also include monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination. This study involves three cohorts, one exposed and two control cohorts: infants who receive Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B). This is a combined prospective and retrospective cohort study. Prospective component of the study identifies and compares study outcomes following Rotarix and IPV vaccination in the Exposed cohort and Unexposed cohort A, respectively. Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedStudy Start
First participant enrolled
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2016
CompletedResults Posted
Study results publicly available
January 25, 2019
CompletedJanuary 25, 2019
June 1, 2018
7.5 years
April 2, 2009
October 30, 2017
August 2, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
60 days following each vaccination
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
7 days following each vaccination
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
30 days following each vaccination
Secondary Outcomes (6)
Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts
60 days following each vaccination
Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts
60 days following each vaccination
Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts
60 days following each vaccination
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
7 days following each vaccination
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
30 days following each vaccination
- +1 more secondary outcomes
Study Arms (3)
HRV cohort
HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).
Concurrent Control cohort
Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).
Recent Historical Control cohort
Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Interventions
Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.
Eligibility Criteria
Children affiliated to two participating health insurance plans.
You may qualify if:
- For Exposed cohort:
- Infants aged less than 1 year at study entry.
- Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- Have complete medical coverage and pharmacy benefits.
- Received at least one dose of Rotarix from 1 August 2008.
- Infants receiving Rotarix liquid formulation will also be eligible.
- For Unexposed cohort A:
- Infants aged less than 1 year at study entry.
- Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- Have complete medical coverage and pharmacy benefits.
- Received at least one dose of IPV vaccine from 1 August 2008, with or without RotaTeq vaccination.
- Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination within the same year.
- For Unexposed cohort B:
- Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- Had complete medical coverage and pharmacy benefits.
- +4 more criteria
You may not qualify if:
- For Exposed cohort:
- Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period.
- For Unexposed cohort A:
- Subject has received any dose of Rotarix prior to the first IPV vaccine during the study period.
- For Unexposed cohort B:
- Subject has received any dose of rotavirus vaccines prior to the first IPV vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Waltham, Massachusetts, 02451, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
April 20, 2009
Primary Completion
November 4, 2016
Study Completion
November 4, 2016
Last Updated
January 25, 2019
Results First Posted
January 25, 2019
Record last verified: 2018-06